Blog of our interpreters and translators for GMP and pharmaceutics

Our blog offers much more than just information about interpreting and translating between Russian, English, and German. Here, we share our insights from GMP inspections by foreign authorities and provide valuable recommendations on how to successfully pass your GMP inspection or audit. You will also periodically receive useful information about the Russian and Belarusian pharmaceutical markets and the market of the Eurasian Economic Union (EAEU). As enthusiastic pharmaceutical interpreters and GMP translators, we are excited to share valuable information about the history of the world's largest pharmaceutical manufacturers and their secrets to success.

Pfizer – GMP-compliant products from Swabia into the whole world

The Spiral, the new headquarters of Pfizer Inc. in New York. The US pharmaceutical company must regularly undergo national and foreign GMP inspections.

In 1849, Karl Pfizer and Karl Erhart moved from Ludwigsburg to New York, where they bought a small production building for borrowed money and founded Charles Pfizer & Company. Today, the former two-person company is considered the world's highest-grossing pharmaceutical group.

The listed US company now produces a wide range of modern medicines at 58 sites worldwide, which are sold in 175 countries. Accordingly, the pharmaceutical company must repeatedly undergo GMP inspections by the authorities in the USA (FDA), the EU (EMA), Russia (SID&GP) and the EAEU (Eurasian Economic Union):

Bitter centre in a sweet shell - Pfizer's first bestseller

These were turbulent times. In 1848, social, economic and political tensions that had been building up in many regions of Europe since the Congress of Vienna in 1815 erupted into violent protests and uprisings. France, the states of the German Confederation and northern Italy were gripped by a revolutionary movement that sought to modernise society and the system of rule. While the social and economic demands were at least partially realised, the political revolution was considered a failure by contemporaries by 1849 at the latest. This realisation triggered an unprecedented wave of emigration of well-trained specialists from all disciplines from Europe to Australia and the USA. There they were referred to as "Forty-Eighters".

The two cousins Karl Pfizer and Karl Erhart were also among them. They came from a middle-class family living in Ludwigsburg. When revolutionary unrest swept across Europe, the businessman and chemist Pfizer and the confectioner Erhart were less than 30 years old. Pfizer had part of his inheritance paid out to him and borrowed an additional 5,000 guilders from his father. With this money in their pockets, the cousins travelled to the USA in 1848. Once on the American East Coast, Pfizer and Erhart acquired a small red-brick building in Williamsburg (Brooklyn). Inside, they set up an office, a warehouse and a production room.

The first product manufactured was Santonin, a remedy for worm infestation, which was widely used at the time due to inadequate everyday hygiene. At the same time, however, the medicine did not have a good reputation due to its unpleasant bitter taste. However, Erhart, a trained confectioner, knew how to solve this problem. He developed a sweet coating, and thus one of the first precursors of today's widely used coated tablets was created at Pfizer. Production at that time had little in common with modern GMP standards. But the solid technical training, inventiveness and thoroughness of the two cousins made Santonin a bestseller for Pfizer. In 1857, a new office was opened in Manhattan. At that time, the company was already the most important supplier of borax and boric acid in the USA and could easily afford the new office. In addition, import duties on tartaric acid from abroad ensured that Pfizer and Erhart began producing tartaric acid during the Civil War, which was used to treat the wounded. In the midst of the war, the two entrepreneurs were naturalised in 1863 and were henceforth known not as ‘Karl’ but as ‘Charles’.

The rise to chemical giant status – thanks to a broad product range

By the time the Civil War ended, Charles Pfizer & Co. had grown to such an extent that another production site was built in Manhattan. In 1876, the company employed 150 workers and four chemists. In addition to borax and tartar, the product portfolio now also included iodine and iodine salts, Seignette salt, ether, chloroform and mercury compounds. At the same time, Pfizer began manufacturing citric acid – a pioneering step, as it would later turn out. In order to keep up with the geographical expansion of the USA, the first branch and warehouse outside New York was opened in Chicago in 1882. In 1890, Charles Pfizer & Co. was transformed into a public limited company, although it remained privately owned until 1942. Charles Erhart died a year later. Charles Pfizer managed the company until 1900 and then retired from management. He died in 1906. He was succeeded by his youngest son Emile Pfizer. Under his leadership, mass production of citric acid became possible in 1919 thanks to a new fermentation technique. This is still used on a large scale by food giants such as Coca-Cola, which, like pharmaceutical companies, are subject to regular GMP inspections and rely on high-quality raw materials.

Pfizer - from chemical to pharmaceutical company

By 1923, Pfizer had become the world's largest manufacturer of citric acid and vitamin preparations. At the same time, the company increasingly focussed on the manufacture of pharmaceutical products. In 1941, Pfizer introduced a process for the large-scale fermentation of penicillin - an expensive and risky step. However, the antibiotic produced this way was many times more effective than conventional penicillin. In this area, the Group also became the largest manufacturer in the world. Expansion picked up speed in the 1950s. By marketing the antibiotic oxytetracycline under its own company name Terramycin®, Pfizer had also become known as a direct supplier. In 1951, branches were opened in Brazil, Canada, England and Panama, among others, followed by the German branch in Karlsruhe in 1958. Such far-reaching internationalisation also required the use of language mediators, and Pfizer became a regular customer for pharmaceutical interpreters and GMP translators. In the 1970s and 1980s, the company launched a range of drugs for diabetes and depression. However, most people associate the name Pfizer with the best-seller Viagra® since 1998 and, since the COVID-19 pandemic, with the Comirnaty® vaccine, which was developed in cooperation with the German company BioNTech.

 

Image: Pfizer, pfizer.com

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